Quality Assurance Manager

2 weeks ago


St Louis, United States a Medical Devices equipment company located in New York Full time

Quality Assurance Manager


RESPONSIBILITIES

  • Ensuring compliance with all Federal, State & Local regulatory requirements for products manufactured at the New York site.
  • Act as the Quality Assurance lead and management representative for the site.
  • Manage and enhance the quality management system at the site.
  • Provide leadership in quality assurance for various functions including quality systems maintenance, material and product release, supply chain, automation, validation, complaints, deviations, CAPAs, and facility engineering.
  • Develop and implement quality procedures to support commercial cGMP production.
  • Supervise quality systems during daily production to maintain high product quality.
  • Lead internal and external audits, and regulatory inspections at the site.
  • Maintain and present Key Performance Indicators and Quality Metrics to Operations and Senior Quality Leadership monthly.
  • Manage quality assurance personnel, including recruitment, training, and development to ensure compliance with cGMP and business objectives.
  • Oversee vendors and suppliers, including auditing as required.
  • Represent the site and company at external events, conventions, seminars, and trainings.


QUALIFICATIONS

  • Minimum 10+ years of experience in the medical devices or biopharmaceutical industries.
  • Must have 5+ years of quality assurance management/supervisory experience
  • Must have working knowledge of current Good Manufacturing Practices (cGMP), FDA regulations and guidance, and 21 CFR 210, 211, and 820.
  • Ability to work with a multidisciplinary team and establish working relationships both internally and externally.
  • Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
  • Experience in hosting regulatory audits/inspections is preferred.
  • Ability to read, understand, and write highly technical material.
  • Proficient in reading, writing, and communicating in the English language.


EDUCATION

  • Bachelor’s degree in life sciences or related field
  • Advanced degree is a plus


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